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Trial record 5 of 5 for:    colon cancer | ( Map: Vietnam )

Asian Subjects With Metastatic Colorectal Cancer Treated With Regorafenib or Placebo After Failure of Standard Therapy (CONCUR)

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ClinicalTrials.gov Identifier: NCT01584830
Recruitment Status : Completed
First Posted : April 25, 2012
Last Update Posted : February 8, 2016
Sponsor:
Information provided by (Responsible Party):
Bayer

Brief Summary:
The purpose of this study is to assess if Regorafenib in combination with best supportive care will slow down tumor progression and result in increased survival in patients with metastatic colorectal cancer.

Condition or disease Intervention/treatment Phase
Colorectal Neoplasms Drug: Regorafenib (BAY73-4506) Drug: Placebo Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 204 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: A Randomized, Double-blind, Placebo-controlled Phase III Study of Regorafenib Plus Best Supportive Care (BSC) Versus Placebo Plus BSC in Asian Subjects With Metastatic Colorectal Cancer (CRC) Who Have Progressed After Standard Therapy
Study Start Date : April 2012
Actual Primary Completion Date : November 2013
Actual Study Completion Date : January 2016

Resource links provided by the National Library of Medicine

Drug Information available for: Regorafenib

Arm Intervention/treatment
Experimental: Arm 1 Drug: Regorafenib (BAY73-4506)
Regorafenib BAY73-4506 will be given 3 weeks on/1 week off (160 mg od po.)

Placebo Comparator: Arm 2 Drug: Placebo
Placebo will be given 3 weeks on/1 week off (160 mg od po.)




Primary Outcome Measures :
  1. Overall Survival (OS) [ Time Frame: From randomization of the first subject untill 154 death events observed, up to 2 years ]
    OS is defined as the time from date of randomization to death due to any cause. Subjects still alive at the time of analysis were censored at their last date of last contact.


Secondary Outcome Measures :
  1. Progression-free Survival (PFS) [ Time Frame: From randomization of the first subject untill 154 death events observed, up to 2 years ]
    PFS was defined as the time from date of randomization to disease progression radiological/clinical or death due to any cause, whichever occurs first. Subjects without progression or death at the time of analysis were censored at their last date of tumor evaluation.

  2. The percentage of subjects with total number of Complete Response (CR) + total number of Partial Response (PR). [ Time Frame: From randomization of the first subject untill 154 death events observed, up to 2 years ]
  3. Disease Control Rate (DCR) [ Time Frame: From randomization of the first subject untill 154 death events observed, up to 2 years ]
    DCR is defined as the percentage of subjects whose best response was not Progressive Disease (PD) according to Response Evaluation Criteria in Solid Tumors (RECIST) (= total number of Complete Response (CR) + total number of Partial Response (PR) + total number of Stable Disease (SD); CR, PR, or SD had to be maintained for at least 28 days from the first demonstration of that rating)

  4. Safety variables will be summarized using descriptive statistics based on adverse events collection [ Time Frame: From randomization of the first subject untill 154 death events observed, up to 2 years ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Histological or cytological documentation of adenocarcinoma of the colon or rectum. All other histological types are excluded.
  • Subjects with metastatic colorectal cancer(CRC) (Stage IV).
  • Subjects must have failed at least two lines of prior treatment.
  • Progression during or within 3 months following the last administration of approved standard therapies which must include a fluoropyrimidine, oxaliplatin and irinotecan.

    • Subjects treated with oxaliplatin in an adjuvant setting should have progressed during or within 6 months of completion of adjuvant therapy.
    • Subjects who progress more than 6 months after completion of oxaliplatin containing adjuvant treatment must be retreated with oxaliplatin-based therapy to be eligible.
    • Subjects who have withdrawn from standard treatment due to unacceptable toxicity warranting discontinuation of treatment and precluding retreatment with the same agent prior to progression of disease will also be allowed into the study.
    • Subjects may have received prior treatment with Avastin (bevacizumab) and/or Erbitux (cetuximab)/Vectibix (panitumumab) (if KRAS WT)
  • Metastatic CRC subjects must have measurable or non measurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST) criteria, version 1.1.
  • Eastern Cooperative Oncology Group (ECOG) Performance Status of 1.
  • Life expectancy of at least 3 months.
  • Adequate bone marrow, liver and renal function as assessed by the laboratory required by protocol.

Exclusion Criteria:

  • Prior treatment with Regorafenib.
  • Previous or concurrent cancer that is distinct in primary site or histology from colorectal cancer within 5 years prior to randomization EXCEPT for curatively treated cervical cancer in situ, non-melanoma skin cancer and superficial bladder tumors [Ta (non-invasive tumor), Tis (carcinoma in situ) and T1 (tumor invades lamina propria)].
  • Extended field radiotherapy within 4 weeks or limited field radiotherapy within 2 weeks prior to randomization.
  • Cardiological disease including Congestive heart failure, Unstable angina, Myocardial infarction, Cardiac arrhythmias requiring anti-arrhythmic therapy.
  • Uncontrolled hypertension. (Systolic blood pressure 150 mmHg or diastolic pressure 90 mmHg despite optimal medical management).
  • Subjects with phaeochromocytoma.
  • Pleural effusion or ascites that causes respiratory compromise.
  • Arterial or venous thrombotic or embolic events.
  • Any history of or currently known brain metastases.
  • Interstitial lung disease with ongoing signs and symptoms at the time of informed consent.
  • Systemic anticancer therapy including cytotoxic therapy, signal transduction inhibitors, immunotherapy, and hormonal therapy during this trial or within 4 week.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01584830


Locations
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China, Guangdong
Guangzhou, Guangdong, China, 510060
Guangzhou, Guangdong, China, 510080
China, Heilongjiang
Harbin, Heilongjiang, China, 150056
China, Jiangsu
Nanjing, Jiangsu, China, 210002
China, Shaanxi
Xi'an, Shaanxi, China, 710032
China, Shandong
Qingdao, Shandong, China, 266003
China, Sichuan
Chengdu, Sichuan, China, 610041
China, Zhejiang
Hangzhou, Zhejiang, China, 310016
China
Beijing, China, 100021
Beijing, China, 100071
Beijing, China, 100142
Changchun, China, 130021
Shanghai, China, 200030
Shanghai, China, 200032
Shanghai, China, 200080
Tianjin, China, 300060
Hong Kong
Shatin, New Territories, Hong Kong
Hong Kong, Hong Kong
Korea, Republic of
Seoul, Korea, Korea, Republic of, 138-736
Taiwan
Taipei, Taiwan, 10016
Taipei, Taiwan, 11217
Taoyuan, Taiwan, 333
Vietnam
Hanoi, Vietnam
Hcmc, Vietnam
Ho Chi Minh City, Vietnam, 84
Sponsors and Collaborators
Bayer
Investigators
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Study Director: Bayer Study Director Bayer

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT01584830     History of Changes
Other Study ID Numbers: 15808
First Posted: April 25, 2012    Key Record Dates
Last Update Posted: February 8, 2016
Last Verified: February 2016

Keywords provided by Bayer:
Regorafenib
Colorectal
Metastatic

Additional relevant MeSH terms:
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Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Colonic Diseases
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Rectal Diseases